The College Of American Pathologists Invites Public Comment On Guideline

Contact: Kerry Lydon, CAP
Phone: (847) 832-7844
E-mail: KLYDON@CAP.ORG

The College of American Pathologists Invites Public Comment on Guideline

Help ensure accuracy: Provide feedback on Quantitative Image Analysis (QIA) of HER2 Immunohistochemistry (IHC) for Breast Cancer

Northfield, IL —The College of American Pathologists (CAP) released draft recommendations for an evidence-based clinical practice guideline for public comment March 7 through March 27, 2017. The expert panel developing these recommendations urges pathologists, especially breast pathologists, pathologist assistants, laboratory personnel, quality managers in laboratories, hospitals, health systems, and vendors to review and comment on the draft recommendations for their upcoming guideline “Quantitative Image Analysis of HER2 Immunohistochemistry for Breast Cancer.”

Advancements in genomics, computing, and imaging technology have spurred new opportunities to use QIA for diagnostic testing. QIA has been shown to improve consistency and accuracy of interpretation compared to manual scoring by pathologists, but it has not gained widespread acceptance. One practical gap is the lack of guidelines for how to perform QIA.

To address the issue, the CAP convened a panel of pathologists, histotechnologists, and computer scientists with expertise in digital pathology (specifically image analysis), immunohistochemistry, and quality management. Led by project chair Marilyn M. Bui, MD, PhD, FCAP, of the Moffitt Cancer Center, Tampa, Fla., the panel drafted the recommendations for improving reproducibility, precision, and accuracy in the interpretation of HER2 IHC where QIA is employed.

“This guideline aims to ensure accuracy within HER2 IHC testing for breast cancer. As innovative digital imaging solutions emerge in pathology, such guidance will be increasingly vital,” Dr. Bui explains. “As with any diagnostic technology, the pathologist’s consistency and accuracy are essential to patient diagnosis, prognosis, and treatment planning.”

The expert panel systematically reviewed 248 relevant articles, examined evidence from 65, and participated in developing 11 draft recommendations. A literature refresh will be conducted during the public comment period to review more recent studies. Following the open comment period, the guideline authors will consider all feedback to finalize the recommendations. The final recommendations will be formally published as a guideline available at no charge.

Through its Pathology and Laboratory Quality Center, the CAP develops evidence-based guidelines and consensus statements related to the practice of pathology and laboratory medicine. Through this work, the CAP and its members continually improve the quality of diagnostic medicine and patient outcomes.

Editor’s Note

The draft recommendations and references provided here represent time-limited information and are not to be distributed, used, or considered as an accurate representation of the group’s work product(s) after Mar. 27, 2017.

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the 2017 CAP Annual Report at CAP.ORG.